(188 days)
Not Found
No
The description focuses on a mechanical clipping device and its physical properties, with no mention of AI/ML or related concepts like image processing, algorithms, or data analysis.
Yes.
The device is used for hemostasis, which is the stopping of blood flow, and closure of GI tract luminal perforations, both of which are therapeutic interventions.
No
The device is indicated for endoscopic clip placement for purposes like marking, hemostasis, and closure of perforations, which are interventional or therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of "two main components, delivery system and clip assembly," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Single Use Hemoclip device is a physical tool used within the gastrointestinal tract for mechanical purposes (marking, hemostasis, closure of perforations). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to direct intervention and manipulation within the body, not laboratory analysis of samples.
Therefore, the Single Use Hemoclip is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
- (2) hemostasis for
(a) mucosal / sub-mucosal defects
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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March 20, 2018
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long Quality Supervisor 301B, No.22, XinYan Road Hanzhou. Zhejiang 311100 China
Re: K172762
Trade/Device Name: Single Use Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: February 5, 2018 Received: February 5, 2018
Dear Lucius Long:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined. The background has a faint watermark.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172762
Device Name Single Use Hemoclip
Indications for Use (Describe)
The Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
- (2) hemostasis for
(a) mucosal / sub-mucosal defects Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image contains a logo for a company called MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in green and blue to the right of the shape. Above the text "MEDNOVA" are some blue Chinese characters.
Section 4 510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China
Contact person: Lucius.Long Telephone: 86-571-89167088-8187 Fax: 86-571-89167086
2. Device
Name of the device: Single Use Hemoclip Classification name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL
3. Predicate device
510(k) Number: K152001, Product Name: Sterile Repositionable Hemostasis Clipping Device
510(k) Number: K161463 Product Name: SureClipTM Repositionable Hemostasis Clip 4. Device description
The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
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Image /page/4/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, followed by the company name in blue and green. The text "MEDNOVA" is in green, and the other text is in blue.
5.Indication for use
The Single Use Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
- (1) endoscopic marking,
- (2) hemostasis for
- (a) mucosal / sub-mucosal defects